VENTRIORecalls & reported problems across all models

We found 18 models of VENTRIO by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 756 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2017 and Sep 30, 2026 — classified as 4 deaths, 731 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Defective Device” (645 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VENTRIO problems

VENTRIO models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VENTRIO 5950040

  Mesh, surgical, polymeric
  109 reports
• VENTRIO 5950050

  Mesh, surgical, polymeric
  92 reports
• VENTRIO 0010215

  Mesh, surgical, polymeric
  82 reports
• VENTRIO 0010212

  Mesh, surgical, polymeric
  81 reports
• VENTRIO 5950030

  Mesh, surgical, polymeric
  1 death71 reports
• VENTRIO 0010211

  Mesh, surgical, polymeric
  62 reports
• VENTRIO 5950020

  Mesh, surgical, polymeric
  52 reports
• VENTRIO 0010214

  Mesh, surgical, polymeric
  1 death33 reports
• VENTRIO 0010213

  Mesh, surgical, polymeric
  30 reports
• VENTRIO 5950070

  Mesh, surgical, polymeric
  29 reports
• VENTRIO 5950060

  Mesh, surgical, polymeric
  23 reports
• VENTRIO 5950080

  Mesh, surgical, polymeric
  21 reports
• VENTRIO 5950090

  Mesh, surgical, polymeric
  1 death19 reports
• VENTRIO 0010218

  Mesh, surgical, polymeric
  14 reports
• VENTRIO 5950010

  Mesh, surgical, polymeric
  1 death11 reports
• VENTRIO 0010216

  Mesh, surgical, polymeric
  10 reports
• VENTRIO 0010219

  Mesh, surgical, polymeric
  9 reports
• VENTRIO 0010217

  Mesh, surgical, polymeric
  8 reports

Recent VENTRIO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion

  MAUDE report 50948304 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Patient problems: Abscess; Wound Infection

  MAUDE report 50594859 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2012 - Patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of Ventralex ST (Device 1). Per op notes, "A incision was made in the area of hernia to the fascia. The hernia sac was identified and the contents were reduced. Adhesions were taken down to free up the preperitoneal space. A Ventralex ST (Device 1) was placed in the preperitoneal space and sutured."(b)(6)2017 - Patient was diagnosed with recurrent incarcerated umbilical hernia and abdominal pain thereby underwent open repair with excision of Ventralex ST (Device 1) and implant of Ventrio ST (Device 2). Per op notes, "A midline incision was made below the umbilicus. The fascia was incised and fat was lifted up. The hernia defect was noted superior to the incision, The old mesh (Device 1) was noted. Adhesions were lysed. The umbilicus was excised and removed. The hernia sac was opened, and the prior mesh (Device 1) was excised and removed entirely. The hernia contents were released. A Ventrio ST (Device 2) was placed and sutured."(b)(6)2017 - Patient was diagnosed with wound dehiscence thereby underwent open repair. Per op notes, "The staples from

  Patient problems: Adhesion(s); Obstruction/Occlusion; Wound Dehiscence

  MAUDE report 50582079 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2011 - Patient was diagnosed with incarcerated ventral hernia with partial small bowel obstruction thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "A semilunar infraumbilical incision was performed with identification of the hernia sac. The viable bowel was placed back within the abdomen. The incarcerated peritoneal fascia and the hernia sac was removed. The fascial defect was identified, dissected. A Ventralex Mesh (Device1) was placed within the defect and secured with sutures."(b)(6)2013 - Patient was diagnosed with moderate intraabdominal adhesions thereby underwent open repair with explant of Ventralex Mesh (Device1). Per op notes, "A midline laparotomy incision was made. The previous umbilical hernia was identified. The two thirds of the previously placed Ventralex Mesh (Device 1) was free floating within the abdomen was excised from the fascia and subcutaneous tissue. Multiple adhesions were excised from abdomen. The fascia was reapproximated with sutures. Splenectomy was performed."(b)(6)2013 - Patient was diagnosed with large incisional hernia, abdominal pain, adhesions thereby underwent open repair with

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50050310 ↗
• InjuryJul 27, 2026Patient-Device Incompatibility

  As reported, the patient underwent an umbilical hernia repair procedure on (b)(6) 2025 with the implant of a Ventrio ST Mesh. About 1 week later, the patient developed an infection on the right side of her incision. An MRI was performed and she was provided antibiotics. The following week, the patient continued with the symptoms of infection, she consulted with a new surgeon who ordered another MRI of her abdomen and determined she was still infected and the mesh needed to be removed. the patient was injected with Botox to help loosen the muscles around her abdominal wall before having the mesh removed. As reported, on (b)(6) 2026 patient underwent removal of the Ventrio ST Mesh. Contact alleges the mesh was infected. No further issues have presented since the removal of the mesh other than some tenderness with bending but no further treatment or recommendations have been provided.

  Patient problems: Medical device site infection

  MAUDE report 50021659 ↗
• MalfunctionJul 27, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50021501 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "THE HERNIA DEFECT WAS IDENTIFIED AND DISSECTED FREE. THE PREVIOUS MESH WAS PLACED FROM PRIOR REPAIR WAS NOTED. THE HERNIA SAC WAS OPENED AND THE CONTENTS WERE REDUCED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SUTURED." (NOTE: THE OLD MESH VISUALIZED IN THIS PROCEDURE WAS UNKNOWN) ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 2). PER OP NOTES, "LOWER MIDLINE INCISION WAS OPENED. THE HERNIA SAC WAS IDENTIFIED AND THE CONTENTS SHOWED THAT THERE WAS SMALL BOWEL HERNIATING THROUGH THE SAC WAS REDUCED. THE HERNIA SAC WAS EXCISED. THE OLD MESH (DEVICE 1) WAS NOTED INTACT. A VENTRIO MESH (DEVICE 2) WAS PLACED AS AN UNDERLAY AND TACKED TO THE OLD MESH (DEVICE 1) USING ABSORBABLE TACKS." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND INFECTION THEREBY UNDERWENT REPAIR WITH DRAINAGE OF THE FOUL-SMELLING FLUID, DEBRIDEMENT OF NECROTIC TISSUES AND PACKED WITH DRESSING. MULTIPLE HERNIA REPAIRS WERE PERFORMED

  Patient problems: Post Operative Wound Infection

  MAUDE report 25666785 ↗
• InjuryMay 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2). PER OP NOTES, "A VENTRIO ST MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2) WERE PLACED INTO THE ABDOMEN USING PROLENE SUTURES." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND INFECTED ABDOMINAL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1 AND 2) AND LYSIS OF ADHESIONS. PER OP NOTES, "THE PATIENT'S UPPER AND LOWER ABDOMINAL WALL MESH (DEVICE 1 AND 2) WERE REMOVED. A XENMATRIX AB (DEVICE 3) WAS PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES."

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 25334922 ↗
• InjuryMay 28, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH IMPLANT OF BARD/DAVOL VENTRALEX MESH ON (B)(6) 2019. POST IMPLANT PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA AS THE EDGE OF THE MESH WAS HERNIATED AND ALSO THE MESH WAS ADHERENT TO THE UNDERSIDE OF THE UMBILICAL STALK. LAPAROSCOPIC REVISION HIATAL HERNIA REPAIR WAS PERFORMED WITH EXCISION OF MESH. ALONG WITH IMPLANT OF BARD/DAVOL VENTRIO MESH ON (B)(6) 2025. PATIENT CONTINUED EXPERIENCING ABDOMINAL PAIN, TEARING SENSATIONS, AND SWELLING. ATTORNEYS ALLEGES THAT THE PATIENT EXPERIENCING RECURRENCE, CHRONIC PAIN, DISABILITY WHICH HAVE IMPAIRED DAILY ACTIVITIES AND UNDERWENT ADDITIONAL SURGICAL INTERVENTION. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 25316635 ↗
• InjuryMay 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE INFRAUMBILICAL AREA, THE HERNIA SAC IN UMBILICUS WAS FREED AND EXCISED CIRCUMFERENTIALLY. AN EXTRA-LARGE PERFIX PLUG (DEVICE 1) WAS PLACED IN THE HERNIA DEFECT AND SECURED WITH SUTURES IN CIRCUMFERENTIAL FASHION AROUND THE UMBILICUS. THE WOUND WAS IRRIGATED AND SUBCUTANEOUS TISSUES WERE APPROXIMATED USING SUTURES.¿ ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA RIGHT TO THE UMBILICUS WAS NOTED. THE PRIOR UMBILICAL REPAIR WITH MESH (DEVICE 1) WAS NOTED AND HERNIA WAS DISSECTED FREE AND REDUCED INTO PREPERITONEAL SPACE. THE PRIOR OLD MESH (DEVICE 1) WAS NOTED AND LEFT IN-SITU. A MEDIUM ROUND VENTRALEX ST MESH (DEVICE 1) WAS PLACED IN PREPERITONEAL SPACE AND SECURED IT WITH SUTURES. THE WOUND WAS IRRIGATED AND CLOSED WITH SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WIT

  Patient problems: Hematoma; Seroma

  MAUDE report 25109859 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND SPIGELIAN HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1), VENTRIO ST MESH (DEVICE 2). PER OP NOTES, ¿HERNIA SAC WITH OMENTUM WAS IDENTIFIED IN THE ABDOMINAL REGION AND THE OMENTUM WAS REDUCED. PREVIOUS MESH AND TACKS WERE FOUND IN LOWER MIDLINE HERNIA REPAIR. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE DEFECT IN LOWER MIDLINE AND TACKED. A VENTRIO ST MESH (DEVICE 2) WAS PLACED OVER THE RECURRENT INCISIONAL HERNIA ON THE LEFT UPPER QUADRANT AND TACKED¿. (NOTE: THE PREVIOUS MESH NOTICED IN THIS PROCEDURE WAS UNKNOWN). (B)(6) 2014- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRIO ST MESH (DEVICE 2), IMPLANT VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, ¿MIDLINE HERNIA HEALED WELL. MIDLINE HERNIA REPAIR MESH (DEVICE 1) WAS IN GOOD POSITION. ADHESIONS WERE TAKEN DOWN AND LEFT FLANK HERNIA WAS IDENTIFIED AND THE OLD MESH (DEVICE 2) WAS EXCISED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED IN THE ABDOMEN COVERING THE ENTIRE DEFECT AND SUTURED¿.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25025883 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL/VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A SUPRAUMBILICAL CURVILINEAR INCISION WAS MADE OVER THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A LARGE VENTRALEX ST MESH (DEVICE 2) WAS PLACED WITH PREVIOUSLY PLACED OLD (DEVICE 1) AND SECURED IT WITH SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE VERTICALLY IN THE MIDLINE ABOVE THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. THE PREVIOUSLY PLACED MESHES WERE IDENTIFIED. BOTH (DEVICE 1) AND (DEVICE 2) WERE EXCISED ENTIRELY. A BIOLOGICAL MESH

  Patient problems: Hernia

  MAUDE report 24801208 ↗
• InjuryApr 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO VENTRIO ST MESH (DEVICE 1 AND 2). PER OP NOTES, "THE PATIENT HAD A VERTICAL MIDLINE INCISION, TWO VENTRIO ST MESH (DEVICE 1 AND 2) WERE PLACED TOGETHER TO THE ABDOMEN USING PROLENE SUTURES." ON (B)(6) 2016 - PATIENT HAD ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF ABSCESS ABDOMINAL WALL. PER OP NOTES, "THE PATIENT HAD A PREVIOUS INCISIONAL HERNIA REPAIR WITH MESH. THERE WAS A SIGNIFICANT AMOUNT OF PURULENCE IN THE ABSCESS CAVITY AND IT WAS DRAINED." ON (B)(6) 2017 - PATIENT HAD STATUS POST ABDOMINAL HERNIA REPAIR WITH EXPOSED MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF EXPOSED MESH (DEVICE 1 AND 2). PER OP NOTES, "THE PATIENT HAD EXPOSED MESH THAT WAS REMOVED.

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 24752337 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1). PER OP NOTES, "A VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1) WAS PLACED TO THE UMBILICUS USING TACKS." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRIO ST (DEVICE 2). PER OP NOTES, "AN UPPER MIDLINE INCISION WAS THEN MADE. THE MESH WAS THEN OPENED AND THERE WAS ADHESIONS UNDERLYING THE MESH, THESE ADHESIONS WERE TAKEN DOWN AND THE MESH (DEVICE 1) WAS REMOVED. A VENTRIO ST MESH (DEVICE 2) WAS PLACED TO THE ABDOMINAL WALL AND A SYNTHETIC MESH ALSO PLACED." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "UMBILICAL HERNIA WAS NOTED AND ABOVE THIS THE INCISIONAL HERNIA WAS ALSO ENTERED. THE PANNUS WAS THEN REMOVED OFF OF THE ABDOMINAL WALL. THE PREVIOUS MESH WAS NOTED."

  Patient problems: Hernia

  MAUDE report 24696337 ↗
• InjuryMar 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE 1). PER OP NOTES, ¿EPIGASTRIC INCISION IN THE MIDLINE WAS MADE. THE HERNIA DEFECT WAS NOTED. A DULEX MESH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES AND ABSORBABLE TACKER. (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH SUBXIPHOID PORT SITE INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿ADHESIONS TO THE PREVIOUS MESH REPAIR TO THE PERIUMBILICAL AREA WAS TAKEN DOWN. THE HERNIA DEFECT WAS IDENTIFIED AND APPROXIMATED WITH SUTURES. A SYNTHETIC MESH WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED WITH SUTURES AND TACKS.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL PORT SITE HERNIA, RECURRENT SUBXIPHOID RIGHT MID QUADRANT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2) FOR SUBXIPHOID DEFECT AND SYNTHETIC MESH FOR RIGHT MID QUADRANT DEFECT. PER OP NOTES, ¿ADHESIONS IN THE SUBXIPHOID AREA WERE TAKEN DOWN AND FREE UP THE LOOP OF BOWEL AND EDGE OF THE LIVER, WHICH WAS ATTACHED TO THE EDGE OF THE MESH, WHICH WAS AT THE SUPERIOR EDG

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 24590391 ↗

Other Davol Inc. products

• VENTRALEX6 models · 2,360 reports
• PerFix16 models · 1,718 reports
• BARD25 models · 1,538 reports
• VENTRALIGHT28 models · 1,284 reports · 2 recalls
• 3DMAX18 models · 1,067 reports
• COMPOSIX18 models · 510 reports
• Hydro-Surg8 models · 307 reports · 2 recalls
• OPTIFIX5 models · 367 reports